Variations requiring assessment (VRA) to the terms of the marketing authorization for a veterinary medicinal product granted via the national procedure are authorized upon application accompanied by all the administrative information and the technical and scientific documentation required by current legislation.
Marketing authorization holders of veterinary medicinal products, their legal representatives or delegated persons or companies.
Variation application with duty stamp accompanied by:
Application form and guidelines
30-60-90 days according to the type, subject to a possible suspension of time limit.
Fee: https://www.salute.gov.it/imgs/C_17_pagineAree_527_1_file.pdf
Stamp duty: A 16,00 Euro duty stamp on the application.
Payment method
Go to Trovanormesalute
Referent Office for Legal proceedings
Direzione Generale della Sanità Animale e dei Farmaci veterinari (DGSAF)
Ufficio 4 - Medicinali veterinari
not present
App Online
Thematic site
Office
Data ultimo aggiornamento: 21 febbraio 2022